alpha-lactalbumin vaccine / Anixa Biosci, Cleveland Clinic - LARVOL DELTA

Phase I trial of alpha-lactalbumin vaccine in patients with high-risk early triple-negative breast cancer (TNBC) and those at genetic risk for TNBC (SITC 2024) - P1 | "Methods We are performing a Phase I trial of recombinant human aLA with GMP-grade zymosan adjuvant in Montanide ISA 51 VG vehicle in 3 cohorts of subjects: 1A) patients with high-risk TNBC who have completed all standard treatment; 1C) patients with TNBC who have residual cancer after primary chemo-immunotherapy and are receiving post-operative treatment with pembrolizumab +/- capecitabine; and 1B) patients with BRCA1, BRCA2, or PALB2 mutations who are undergoing risk-reducing mastectomies. Immune data in these new cohorts will be reported. Data from this trial will be insufficient to assess clinical efficacy and will be explored in Phase II.View this table:View inline View popup Download powerpoint Abstract 631 Table 1 CTCAE injection site reactions by dose level and grade"

Clinical • IO biomarker • P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • IFNG • IL17A • PALB2

Anixa Biosciences Granted First Australian Patent for its Breast Cancer Vaccine, Broadening Global Protection Through 2040 (Yahoo Finance) - "...announced that IP Australia has issued Patent Number 2020221280 related to Anixa's breast cancer vaccine technology, exclusively licensed from Cleveland Clinic. This composition-of-matter patent protects the Company's novel approach to breast cancer prevention and treatment in Australia through 2040, addressing a disease for which no preventive vaccine is currently approved anywhere in the world."

Patent • Triple Negative Breast Cancer

Anixa Biosciences to Present at the 2026 Cantor Fitzgerald Global Healthcare Conference Highlighting its Breast Cancer Vaccine…Therapy (PRNewswire) - "Mike Catelani, President, COO & CFO of Anixa, will deliver a presentation highlighting Anixa's breast cancer vaccine, being developed in collaboration with Cleveland Clinic, which completed a Phase 1 clinical trial that was funded by the U.S. Department of Defense. The trial met all primary endpoints, including safety, and protocol-defined immune responses were generated in 74% of participants."

P1 data • Breast Cancer

Anixa Biosciences to Present at the H.C. Wainwright 28th Annual Global Investment Conference (PRNewswire) - "Dr. Amit Kumar, Chairman and CEO of Anixa, will deliver a presentation that will be available to view beginning at 7:00 AM ET, Friday, September 11, 2026. Dr. Kumar's presentation will highlight Anixa's breast cancer vaccine, being developed in collaboration with Cleveland Clinic, which completed a Phase 1 clinical trial that was funded by the U.S. Department of Defense. The trial met all primary endpoints, including safety, and protocol-defined immune responses were generated in 74% of participants. Preparations are underway for a Phase 2 trial."

New P2 trial • P1 data • Breast Cancer

CASE6119: Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: George T. Budd | Active, not recruiting ➔ Completed | Trial completion date: May 2026 ➔ Dec 2025

Trial completion • Trial completion date • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • ER • HER-2 • PGR • PRL

Anixa Biosciences Expands Global Patent Portfolio with Australian Patent Acceptance for Breast Cancer Vaccine Technology (PRNewswire) - "This patent, exclusively licensed from Cleveland Clinic, will provide protection for the Company's novel approach to breast cancer treatment and prevention in Australia....The Australian patent complements patents issued in the United States and other key global jurisdictions, including Europe, China, and Japan, among others, and represents an important step toward potential future regulatory approvals and commercialization efforts outside the United States."

Patent • Breast Cancer

Anixa Biosciences…announced that the Korean Ministry of Intellectual Property (MOIP) has issued Patent Number 10-2960889 related to Anixa's breast cancer vaccine technology (PRNewswire) - "This composition-of-matter patent, exclusively licensed from Cleveland Clinic, protects the Company's novel approach to breast cancer prevention and treatment in South Korea through 2040, addressing a disease for which no preventive vaccine is currently approved anywhere in the world....The Korean patent complements Anixa's existing patent portfolio in the United States and other key international markets, further strengthening the Company's global intellectual property estate. The expanded patent protection enhances Anixa's ability to pursue future regulatory approvals, strategic partnerships and commercialization opportunities."

Patent • Breast Cancer

Anixa Biosciences Reports Positive Data from Completed Breast Cancer Vaccine Phase 1 Trial and Positive Survival Observations from Ongoing CAR-T Phase 1 Trial at New York Academy of Sciences' Frontiers in Cancer Immunotherapy Symposium (PRNewswire) - "The Company's breast cancer vaccine presentation...reported final Phase 1 findings for the investigational vaccine, including that all major primary endpoints were met, the vaccine was safe and well tolerated at the maximum tolerated dose based on safety and tolerability, and protocol-defined immune responses were elicited in 74% of trial participants. The Company's lira-cel presentation...reported the clinical trial design and objectives, as well as the current status of Anixa's ongoing Phase 1 clinical trial of lira-cel, including survival observations of multiple patients living over one year past treatment."

P1 data • Trial status • Ovarian Cancer • Triple Negative Breast Cancer

Anixa Biosciences…announced that the Mexican Institute of Industrial Property (IMPI) has issued Patent Number 432748, covering key aspects of the Company's breast cancer vaccine technology (PRNewswire) - "This patent issuance builds upon the Company's broad and expanding intellectual property portfolio, extending foundational patent protection for the breast cancer vaccine program into the 2040s in multiple jurisdictions throughout the world."

Patent • Breast Cancer

Anixa Biosciences to Participate in RedChip's Biotech Resurgence: Platforms and Pipelines of Today's Innovators Conference on April 16, 2026 (Anixa Biosciences Press Release) - "The presentation will cover several topics, including an overview of the Company and its business model, the Company's breast cancer vaccine meeting primary endpoints and generating protocol-defined immune responses in 74% of participants in its Phase 1 clinical trial, and the Company's ovarian cancer CAR-T therapy, lira-cel, exhibiting positive survival data in its ongoing Phase 1 clinical trial."

P1 data • Ovarian Cancer • Triple Negative Breast Cancer

Anixa Biosciences…announced that it has entered into a development and manufacturing agreement with Cytovance Biologics…to produce cGMP clinical materials for its planned Phase 2 clinical trial of its breast cancer vaccine (PRNewswire) - "The agreement follows positive final Phase 1 results in which the investigational vaccine met all primary endpoints, was safe and well tolerated at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants. Based on these results, Anixa is advancing preparations for a Phase 2 clinical trial."

Licensing / partnership • New P2 trial • Breast Cancer

Anixa Biosciences Receives Notice of Allowance from Korean Ministry of Intellectual Property (MOIP) for Patent Covering Breast Cancer Vaccine Technology (PRNewswire) - "This patent, exclusively licensed from Cleveland Clinic, will provide composition of matter protection for the Company's novel approach to breast cancer treatment and prevention in South Korea. The patent is titled, 'Vaccine Adjuvants and Formulations', and the co-inventors are Dr. Justin Johnson and the late Dr. Vincent Tuohy, both of Cleveland Clinic."

Patent • Breast Cancer

Anixa Biosciences…announced that it will host its 2026 Annual Meeting of Stockholders (the 'Meeting') on Tuesday, March 10, 2026… (Yahoo Finance) - "The presentation will include a review of recent clinical milestones across the Company's oncology pipeline, including: (i) Encouraging survival observations and regulatory approval for substantial dose escalation in the Company's ongoing Phase 1 ovarian cancer CAR-T trial; and (ii) Final Phase 1 data from the breast cancer vaccine program, which met primary endpoints and demonstrated favorable tolerability and protocol-defined immune responses in the majority of participants."

P1 data • Platinum resistant • Breast Cancer • Ovarian Cancer

Anixa Biosciences Receives Notice of Allowance from Mexican Institute of Industrial Property (IMPI) for Patent Covering Breast Cancer Vaccine Technology (PRNewswire) - "This patent, exclusively licensed from Cleveland Clinic, will provide composition of matter protection for the Company's novel approach to breast cancer treatment and prevention in Mexico. With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Mexican patent complements patents issued in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S."

Patent • Triple Negative Breast Cancer

Anixa Biosciences, Inc…announced that it has completed the transfer of the Investigational New Drug application ("IND") for its breast cancer vaccine from Cleveland Clinic. (PRNewswire) - "Anixa is now the trial sponsor for future development of its breast cancer vaccine....With enrollment completed and encouraging immune response and safety data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and has assumed full sponsorship of the IND. Anixa plans to utilize multiple clinical sites, including Cleveland Clinic, for the Phase 2 and other clinical trials."

IND • Breast Cancer

Anixa Biosciences Announces Positive Phase 1 Data for Investigational Breast Cancer Vaccine; Primary Endpoints Were Met and Immune Response Observed in 74% of Participants (PRNewswire) - "All major primary endpoints were met; 74% of participants demonstrated protocol-defined immune responses; α-lactalbumin (aLA)-specific T cell responses were observed per protocol-defined criteria; Vaccine was safe and well tolerated at the MTD, with adverse events primarily injection-site irritation; Preliminary Immunohistochemistry (IHC) of primary tumors showed aLA expression ranging from absent to strong; analyses correlating expression to immune response and clinical outcomes are ongoing."

P1 data • Triple Negative Breast Cancer

Anixa Biosciences…announced that the United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,472,205 on November 18, 2025, covering key aspects of the Company's breast cancer vaccine technology (PRNewswire) - "The patent protects novel methods of inducing an immune response to α-lactalbumin protein-a protein typically found only in normal breast tissue during lactation but also expressed in certain breast cancers, making it an attractive target for immunoprevention strategies....This patent issuance builds upon the Company's broad and expanding intellectual property portfolio, strengthening foundational patent protection for the breast cancer vaccine program into the mid-2040s."

Patent • Breast Cancer

Anixa Biosciences…announced that it has executed a data transfer agreement ("DTA") with Cleveland Clinic, as a key step in the process of transferring the breast cancer vaccine clinical trial data and sponsorship to Anixa for future clinical development (PRNewswire) - "...Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND. The IND, currently sponsored by Cleveland Clinic, is in the process of being transferred to Anixa. The DTA will allow for the transfer of all relevant data and information, collected and generated from the Phase 1 clinical trial, to Anixa."

IND • Licensing / partnership • Breast Cancer

Anixa Biosciences…announced that the Chinese National Intellectual Property Administration (CNIPA) has issued Patent Number ZL2020800215666, covering key aspects of the Company's breast cancer vaccine technology (PRNewswire) - "Expands global intellectual property coverage in markets with high breast cancer incidence. New patent will provide IP protection of Breast Cancer Vaccine in China into 2040."

Patent • Breast Cancer

Anixa Biosciences Announces Completion of Final Patient Visit in Breast Cancer Vaccine Clinical Trial (PRNewswire) - "The trial enrolled 26 patients in the TNBC group, four in the Prevention group, and five in the Pembrolizumab group....Following analysis, a final study report will be submitted to the Department of Defense, and a Clinical Study Report (CSR) will be filed with the U.S. Food and Drug Administration (FDA). Cleveland Clinic will present full clinical results at the San Antonio Breast Cancer Symposium on December 11, 2025."

P1 data • Trial status • Triple Negative Breast Cancer

Anixa Biosciences Receives Notice of Allowance from Chinese National Intellectual Property Administration for Patent Covering Breast Cancer Vaccine Technology (PRNewswire) - "Notice of Allowance marks first Chinese patent to be issued on Anixa Breast Cancer Vaccine. Expands global intellectual property coverage in markets with high breast cancer incidence. New patent will provide IP protection of Breast Cancer Vaccine in China into at least the 2040s."

Patent • Breast Cancer

Anixa Biosciences Announces Commencement of US FDA Approved IND Transfer to Support Upcoming Phase 2 Breast Cancer Vaccine Trial (Yahoo Finance) - "Anixa Biosciences, Inc...announced that, in collaboration with Cleveland Clinic, it has initiated the transfer of the Investigational New Drug (IND) application that supported the Phase 1 clinical trial of its breast cancer vaccine. With enrollment completed and encouraging immune response data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND."

IND • Breast Cancer • Triple Negative Breast Cancer

Anixa Biosciences Receives Notice of Allowance from Canadian Intellectual Property Office for Patent Covering Breast Cancer Vaccine Technology (PRNewswire) - "Anixa Biosciences...announced that the Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for a new patent related to its breast cancer vaccine technology. This patent, exclusively licensed from Cleveland Clinic, will provide composition-of-matter protection for the Company's novel immunogenic approach to breast cancer prevention and treatment in Canada. With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunoprevention. The Canadian patent complements issued and pending patents in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S."

Patent • Breast Cancer

Anixa Biosciences Awarded New U.S. Patent Extending Breast Cancer Vaccine IP Protection into 2040s (PRNewswire) - "Anixa Biosciences...announced that the United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,370,244 on July 29, 2025, covering key aspects of the Company's breast cancer vaccine technology. The patent protects novel methods of immunizing patients against breast cancer by administering an immunogenic composition containing human α-lactalbumin protein...making it an attractive target for immunoprevention strategies....The vaccine was invented at Cleveland Clinic, and this patent-along with others related to this technology-has been exclusively licensed to Anixa Biosciences. This issuance builds upon the Company's broad and expanding intellectual property portfolio, extending foundational patent protection for the breast cancer vaccine program into the mid-2040s."

Patent • Breast Cancer

Breast cancer vaccine shows promising results in phase 1 clinical trials (India Today) - P1 | N=35 | NCT04674306 | "A new breast cancer vaccine has completed phase 1 clinical trials, showing promising results....The trial involved 35 high-risk women, with over 75% developing a strong immune response. Phase 2 trials are set to begin in 2026, marking a significant step towards potentially preventing breast cancer."

New P2 trial • P1 data • Breast Cancer • Triple Negative Breast Cancer